CASI Pharmaceuticals, a US-based biopharmaceutical company, will expand its presence in China by entering into a long-term manufacturing agreement with Chinese Yiling Wanzhou International Pharmaceutical Co. Ltd for the manufacturing of two of its drugs, entecavir and cilostazol.
Yiling Wanzhou International Pharmaceutical is a subsidiary of Shijiazhuang Yiling Pharmaceutical Co. Ltd.
Entecavir has been approved by the U.S. Food and Drug Administration for the treatment of chronic hepatitis B, while cilostazol is recommended to treat the reduction of symptoms of intermittent claudication or cramping pains. Entecavir is an HBV nucleoside analog reverse transcription inhibitor that interferes with HBV replication.
“We are very pleased to partner with Yiling Wanzhou International as our manufacturing site for entecavir and cilostazol,” said Ken Ren, CASI’s chief executive. “Through this partnership, we will leverage Yiling’s manufacturing knowledge and capabilities in order to provide high-quality, cost-effective medicines that are critically needed for patients both in China and the US.”
The contracted manufacturing facilities have been inspected by both the U.S. Food and Drug Administration (FDA) and China FDA (CFDA) and operate to strict International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Manufacturing Practice (GMP) standards. Entecavir and cilostazol are part of the 29 abbreviated new drug applications (ANDAs) that CASI acquired from Sandoz in January 2018
CASI is a biopharmaceutical group which is headquartered in Rockville, Maryland, but maintains a wholly owned subsidiary and research and development operations in Beijing, China.